How PF-08653944 affects stomach emptying in adults with overweight or obesity
A PHASE 1, OPEN-LABEL, MULTIPLE DOSE STUDY TO INVESTIGATE THE IMPACT OF PF 08653944 ON GASTRIC EMPTYING IN ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
PHASE1 · Pfizer · NCT07508241
This study will test whether PF-08653944 changes how quickly the stomach empties after a meal in adults who are overweight or have obesity.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Pfizer (industry) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT07508241 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study gives PF-08653944 to generally healthy adults with BMI 27–45 kg/m² to measure its effect on gastric emptying. Participants receive the study medicine for a short period and will take acetaminophen as part of a standard absorption test to track how quickly stomach contents pass into the intestine. Investigators will collect blood samples and timed measurements after dosing to characterize drug effects and absorption while monitoring safety. Safety assessments including laboratory tests, ECGs, and physical exams will be performed during the study visits.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 18 or older with BMI 27–45 kg/m² and body weight over 50 kg who do not have diabetes and have not recently used GLP‑1 receptor agonists.
Not a fit: People with diabetes, significant medical conditions, recent GLP‑1 agonist use, or BMI/weight outside the required ranges are unlikely to qualify and would not be expected to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, results could help researchers optimize dosing and predict digestive effects that may inform future obesity treatments.
How similar studies have performed: Other weight‑management drugs that affect gut motility have produced measurable changes in gastric emptying in prior studies, so the approach has precedent, though PF‑08653944 itself is being tested early.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults ≥18 years at screening, male or female, generally healthy as determined by medical history, physical examination, laboratory tests, and ECG. * Body mass index (BMI) 27-45 kg/m² and body weight \>50 kg (110 lb). * Participants with overweight or obesity Exclusion Criteria: * History or presence of clinically significant medical conditions, including but not limited to: --Cardiovascular, hepatic, renal, pulmonary, endocrine, hematologic, neurologic, gastrointestinal (including pancreatitis or gallbladder disease), or significant psychiatric disorders. * Any form of diabetes, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg/dL. * Prior exposure to a GLP-1 receptor agonist within 90 days before first dose, or prior participation in a study with PF-08653944.
Where this trial is running
New Haven, Connecticut
- Pfizer Clinical Research Unit - New Haven — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Overweight and/or Obesity, Overweight, Drug Interaction